510(k) K150419 ยท OUB Instrument For Treatment Of Hyperhidrosis
miraDry System MD4000
| Applicant | Miramar Labs, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Jun 19, 2015 |
| Received | Feb 18, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150419
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 6, 2015 | Miramar Labs, Inc. miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-BT miraDry bioTip and accessories.
General and Plastic Surgery: The miraDry System is intended for Terminated |
OUB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.